Attachment_1_RFP_Questions_for_BARDA_Responses_6.26.2016_final.pdf

RFP-16-100-SOL-00010

Amendment # 0002 - Attachment 1

# Section Page Question Responses

1 B.3.2 6 Option 1 includes “instrument test definition software” but does not specify any hardware upgrades that may also be necessary. Please confirm that any necessary hardware updates are also included in Option 1.

Page 6 says "Manufacture and the delivery of biodosimetry tests, reagents and instrument test definition software" is required for Option 1.

Option 1 includes a plan and all material preparation for doing upgrades but does not include doing the upgrades because no contract is in place for the laboratory services.

2 B.3.2, F.1 6, 23 F.1 states that Options 2-6 include “maintenance.” Please clarify what maintenance this covers. The language used in B.3.2 does not state “maintenance.”

Page 6 says "Manufacture and the delivery of biodosimetry tests, reagents and instrument test definition software". Maintenance refers to maintenance of the stockpiled items.

3 B.3.2.1 7

Option 6 on page 7 appears to be incomplete. It states “…which may include:”

but nothing thereafter. Is BARDA looking for firm pricing for this option now, or just a summary of possible activities, which would be further scoped and proposed at a later time?

Page 7 states "Biodosimetry High-Throughput Test Upgrade" and the far right column is "Cost Plus Fixed Fee" . The amendment now includes the following bullet points:

o A detailed plan of how the upgrade could be accomplished and the regulatory implications of the upgrade o Evidence that the upgrade can be cleared by the FDA o A timeline and estimated cost to accomplish the upgrade The Option is intended to be a cost reimbursement CLIN. The USG is looking for firm pricing for the option now.

4 C.2 13 Section C.2 is not clear regarding which of the listed objectives must be accomplished under the base contract (CLIN 0001) versus the options (CLIN 0002- 0007). Please clarify.

Page 5, first footnote states "Business proposals shall include labor rate costs, facility costs, and all other costs necessary to complete test validation, filing pre-EUA and FDA approval documents, completing test definition software package, and initial manufacturing of the first portion (40,000 tests) of the radiation biodosimetry reagents and assay kits and the last footnote states "Initial manufacturing upon the test receiving EUA status." At a minimum, all of the items listed in C.2.1 should be accomplished in CLIN 0001. To be ready to fulfill the stockpile needs within 9 months after the FDA action, other items in C.2. may also need to occur. This will be test dependent. CLIN 0002-0007 are optional CLINS that may be exercised to fulfill stockpile needs.

5 C.2.4-3 16 Section refers to “table below” but none is shown.

No table is outlined below, Attachment #12 contains the table as it relates to BARDA Security Requirement. The table is entitled BARDA Security Requirements.

6 C.2.6 17 Is the Contractor required to conduct initial training within the labs as part of production deployment where the instruments are placed and where the tests will be run? Or only prepare the training material?

Yes, reference section C.2.6 which states "Prepare the training materials.• Provide appropriate training material• Provide an operationalization plan describing a feasible scenario for laboratories that could be contracted to run the assays at the volume needed for a nuclear detonation response. • Identify a series of CAP-certified, CLIA-regulated laboratories that have the capability to run and report the test results on up to 400,000 clinical samples in 7 days."

7 C.2.11, C. 19 How does C.2.11 differ from the scope that is described in C.2.8? Does C.2.8 apply to Option 1 while C.2.11 applies to Options 2-5?

C.2.8 is intended to cover initial stocking and routine replenishments. C2.11 is intended to cover replenishment after a catastrophic event (such as nuclear terrorism or nuclear plant meltdown). See page 5 CLIN 0001 footnote- the base includes manufacturing 40,000 if the test reaches EUA status.

8 C.2.7, C.4 18, 20 C.2.7 states that the kickoff meeting “usually occurs within a month after contract award.” C.4 states that “the Contractor and USG shall conduct a kickoff meeting within 45 calendar days after the contract award.” Please clarify which applies.

C.2.7 will be amended to say the kick-off will be with 45 days after contract award.

9 F.4, 14.0 34 Please confirm that violations that need to be reported are ones related to the Biodosimetry contract only.

Should a security violation occur, it must be reported by the prime of this BARDA funded biodosimetry contract.

10 G.3, G.4 35, 36 Please clarify if the Contractor needs to provide names as part of the proposal, or if this will be determined at a later date?

The Contractor will need to provide the names in the proposal. They can be amended prior to award and changed by modification after award.

11 Cover, L.6 1, 104 Please clarify the proposal validity time. Is it 150 days as shown on the cover sheet or 270 days as called out in L.6?

Page 1 will be amended to 270.

12 L.6 - 2 104 Please clarify what information is being requested on current commitments.

Current commitments refers to labor or financial commitments that might impede accomplishing the work or providing deliverables in accordance with the contracted time and quality.

13 E.1.1 21 Do the audits include a financial audit? They may include financial audits pertaining to the contract.

14 B.2 4

Please clarify the 7th stated requirement. Does analytical performance need to be demonstrated within approximately 1 year of contract award, does design validation need to begin within 1 year, does a pre-market clearance need to be obtained within approximately 1 year of contract award, or does an EUA need to be obtained within approximately 1 year of contract award?

Another way to state the 7th requirement is: Has completed formal test verification (per FDA guidelines) and obtained results that warrant moving into formal test validation within one year of contract award.

15 F.4 - 3.0 30 Please confirm that the progress report must include actual cost information for CPFF CLINS only, not FFP CLINS.

That is correct. That sentence will be amended to say "and cumulative Cost Plus Fixed Fee costs to date".

16 F.4 - 7.0 31 Please clarify that this will be limited to SOPs relevant to the product being built and tested, and will only be released under appropriate NDA.

Perhaps the verbiage could be changed to "SOPs relevant to the product being built and tested and those that impact the performance of the contract (such as but not limited to physical security, IT security and backup, root cause analysis and corrective action plans)"

17 L.2.2 93, 94

Our company information security policy restricts emailing proprietary information without encryption (through a password, encrypted WinZip file, or through secure FTP server). Please provide a secure method of electronic delivery for proprietary information.

The Contractor will need to provide the requested files in a manner that satisfies the RFP requirements. Perhaps a CD-ROM or USB Drive could be delivered by hand or delivery service and the password could be provided via email to the CO. The hard-copy documents could also be hand or courier delivered in a locked box or combination envelop and the entry codes could be emailed or phoned to the CO.

18 L.5.2 97 Does the USG have a preferred format for Section 3 of the Business Proposal?

What level of detail is required for the basis of estimates, given the 50 page count restriction.

The USG does not have a preferred format for Section 3 of the Business Proposal.

Provide the level of detail described in accordance with L.5.2 Section 3.

19 L.4.1, L.5. 95, 97 Does cover page and table of contents count against the page count? Yes

20 L.5 97 Does the Small Business Plan count against the 50 page limit, or is it an appendix? The Small Business Plan is an Appendix.

21 L.5.2 97 Since this is a full and open competition, please confirm that providing fully burdened prices (inclusive of all indirect costs) for labor, materials, subcontracted items, travel, and other costs is sufficient on the FFP CLINS?

Fully burdened prices are to be provided for FFP CLINS.

22 L.4.1, L.5. 95 Please clarify if the Security Plan needs to be provided with the proposal response, or if it is a contract deliverable as described in C.2.4 para 3.

A brief description of the Contractor Security Plan is needed as part of the RFP response. See Section H.25. It states the full security plan is due within 60 days of award and a remediation plan (if needed) must be delivered within 120 days.

23 1 Typo on due date. It initially read 07/2216. It is 07/22/2016. This has already been corrected in amendment 1 on FedBizOpps

24 C.2.1 13

It is our understanding that filgrastim and Leukine will only be used for treatment upon initial assessment at the hospital. It our expectation that the blood for initial biodosimetry would be collected before giving GCSF. Based on this assumption, please confirm that there is neither a requirement for the test to determine irradiation status or provide an accurate dose after treatment with filgrastim and Leukine. It is our expectation that measurements post-treatments would be used for secondary confirmation and retesting. Thus, the assay performance and design of associated studies is for product labeling/supportive information and the studies do not need to be powered to the same level as primary dosimetry assessment.

The RFP states an NHP study will be required on page 13 "An NHP study of filgrastim (10mg/kg/sc), Leukine (6.1 µg/kg/sc), and other agents held in the SNS plus irradiation compared to irradiation alone" . The results will be for product labeling. The design will be part of the validation plan submitted to the FDA.

25 C.2.1 NHP Studies. Please confirm that the contractor will be responsible for procurement of NHPs as well as overall design and management for the required studies in CLIN1 and should be directly requesting quotes from qualified suppliers

Yes the contractor will be responsible for the studies on page 13. "The contractor will submit to the Contracting Officer for review and acceptance the proposed protocols, on-going status reports and final reports for" the NHP studies.

26 General Please confirm that the Federal Executive Level II pay scale is $183,300 for salary limitation determination. Is there a new limit for 2016? Are there waivers for FFP Contracts?

The 2016 FEL II pay scale is $185,100. Please see:

http://grants.nih.gov/grants/policy/salcap_summary.htm There are no salary limitation waivers.

27 General What regulatory group will be managing the provisions of FAR 52.216-7? DCAA, HHS?

HHS will be administering the contract.

28 General Do CLINs 2-6 fall under the definition of commercial items IAW FAR 12.102(f)(1)? Yes, CLINs 0002-0006 are FFP commercial items.

http://grants.nih.gov/grants/policy/salcap_summary.htm http://grants.nih.gov/grants/policy/salcap_summary.htm http://grants.nih.gov/grants/policy/salcap_summary.htm

29 L.6. 104 What’s meant by a “demonstrated” accounting system?

See page 104 of the RFP- "The accounting system must accomplish the following:

1. Identifies and segregates direct and indirect costs by cost element

2. Identifies varying levels of indirect costs (e.g. fringe benefits, labor related overhead, and G&A costs)

3. Provides actual cost data at interim periods to allow for contract re-pricing or negotiating revised contract targets

4. Accumulates costs on both a current and cumulative basis (e.g. year to date, and project to date).

5. A timekeeping system that identifies employees’ labor costs to appropriate cost objectives to facilitate accurate recording of employee labor costs.

6. Establishes the accounting period and perform reconciliations of time sheets to labor costs included in job cost ledgers and of basic cost records to the general books of account.

7. Excludes from costs charged to government contracts, amounts which are not allowable per terms of FAR Part 31, contract Cost Principles and Procedures, and augmented by CAS 405."

HHSAR 352.242-74 (page 5) in current regulations is not listed on the HHS website. Do you have a copy?

HHSAR 352.242-17 is not a current regulation and has been removed from the RFP.

31 B 4.7. 10

Under section B 4.7. “BARDA may share technical deliverables and test results created in the performance of this Contract with colleagues within the Integrated Portfolio”. What precautions are made to protect proprietary and confidential elements? Who does “Colleagues within integrated portfolio” refer too? Does BARDA intend to share these data with other diagnostic participants in the program?

"Colleagues within the integrated portfolio" refers to the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) Integrated Portfolio Advisory Committee (PAC), which includes members from the DOD, FDA, NIH, NCI, CDC, DHS, and BARDA per page 11 of the RFP. See http://www.phe.gov/Preparedness/mcm/phemce/Pages/governance.aspx. In addition, please see page 59 of the 2014 Public Health Emergency Medical countermeasures Strategy and Implementation Plan for greater detail.

32 H.7 59

Clause h.7 Page 59 Requires full Earned Value Management System in accordance with HHSAR 334.201. The reference guidance indicates this method is discouraged for FFP contracts so does this just apply to CLIN 1 and 7? Is the method desired similar to the efforts from the biodosimetry development contracts or is full work package planning and cost management desired?

Earned Value Management System should be applied to the cost plus fixed fee CLINs only.

Manufacturing Scheduling and Stockpile Replenishment - The RFP calls for delivery of kits to be within 9 Months of the contract option approval. Is the desired delivery all 400K units in one shipment? Or is there a staggered replenishment rotation envisioned (ie annually or semi-annually)?

Please propose replenishment in a manner that offers the best value for the government.

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